A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

To join this study, you generally need to be an adult between 18 and 99 years old with an ongoing Hepatitis Delta infection. Your Hepatitis Delta virus levels and a common liver enzyme called ALT would need to be above certain levels when checked by the study doctors. Also, you must be willing to take, or already be taking, medication to treat Hepatitis B, as these two infections often occur together.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you are unable to use contraception reliably during the study, you would not be eligible. People with other serious liver conditions (like severe alcohol-related liver disease or liver cancer) or those who have had an organ transplant would also not be able to participate. Having existing serious liver complications, such as fluid build-up in the tummy (ascites), would also prevent participation, as the study aims to test these treatments in a specific group of patients.

If you join this study, you'll be randomly assigned to one of two treatment groups, much like flipping a coin for fairness. Both groups receive their study medication as an injection under the skin (subcutaneously).

* **Group 1:** You'll receive brelovitug at a dose of 300 mg once a week for a total of 96 weeks (about 1 year and 10 months). * **Group 2:** You'll receive bulevirtide at a dose of 2 mg once a day for the first 48 weeks (about 11 months). After this, you'll switch to brelovitug at a dose of 300 mg once a week for the next 48 weeks.

Throughout the study, you will have regular visits to the clinic for medical checks, blood tests, and to assess how you are responding to the treatment and to monitor for any side effects. The total duration of active treatment for both groups is 96 weeks. After this, there will likely be follow-up appointments to monitor your long-term health.